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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

Amsphere A3

JSR Life Sciences


Featured Articles

Overcoming Obstacles in AAV Viral Vector Manufacturing

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

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Headline News

Roche receives CE Mark for compact cobas smart e immunoanalyser


FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


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Past Webinars

Characterization of Biotherapeutics

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia and Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific
24th September 2019


Challenges and Risks in Development and Manufacture of Covid 19 Vaccines

Presented by Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac, Harish Rao, General Manager at Serum Institute of India Ltd, Amar Shrivastava, Senior Manager  at Serum Institute of India Ltd
30th June 2020


Development of automated chemometric platform for accelerated Raman-based model optimization in biologics

Presented by Oliver Steinhof, PAT Scientist at Biogen and Nicolas Langenegger, Senior Associate Scientist at Biogen and Followed by Brian Rohrback, President and CEO of Infometrix, Inc.
20th September 2021


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